Clean Room and HVAC Validation / AHU Validation / Qualification
* HVAC validations as per ISO 14644-1,2,3, EU GMP/EC GMP, WHO-TRS-937, WHO-TRS-961, Schedule M (National Regulatory Body) guidelines for all room classifications.
Cleanroom Certification
validated cleanrooms are validated to a required class of cleanliness. The level of cleanliness chosen is driven by user requirements. Cleanroom classes are defined in ISO1464-1:
Monitor And Control
A constant monitoring program is required after certification. Requirements for compliance are found in ISO 14644-2.
Methods for evaluation and measurements for Certification are specified in ISO : 14644-3. It calls out for the following ten tests.
Air flow Test & ACPH Calculations
Installed Filter System Leakage Test (using PAO)
Non-Viable Particle Count Test
Recovery Test
Air Flow Pattern Test (Using Water Fogger)
Air Pressure Balancing
Containment test
Temperature & RH Measurement
Light Intensity Measurement
Sound Level Measurement
Range of services pertaining to Clean Room Validation
High Pressure Diffuser
FOG Generator
Handy Camera
Particle Counter
Aerosol Photometer
Aerosol Generator
Air Capture Hood
Vane Type Anemometer
Laminar Air Flow Unit (LAF)
Reverse Laminar Air Flow Unit (RLAF)
Dispensing/Sampling Booth
Bio Safety Cabinet
Garment Cubicle
Sterilizing Tunnel
Dry Heat Sterilizer (DHS)
Animal Changing Station
Individual Ventilation Cage (IVC Unit)
Fluid Bed drier (FBD)
Autocoater – Tablet Coating machine
ULPA Filter Integrity test
HVAC Validation includes following Tests:
Air Velocity Test
Filter Leak Test
Air Flow Pattern Test
Non viable Particle Count
Viable Particle Count
Recovery Test
Differential Pressure Monitoring
Temperature & Relative Humidity Monitoring
Noise & Light Level Measurement
What is validation?
Validation is a process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in production or testing maintains the desired level of compliance at all stages.
In Pharma Industry it is very important apart from final testing and compliance of product with standard that the process adapted to produce itself must assure that process will consistently produce the expected results
Here the desired results are established in terms of specifications for out come of the process. Qualification of systems and equipment is therefore a part of process of validation.
It is a requirement of food and drug, pharmaceutical regulating agencies like FDA's good manufacturing practices guidelines. Since a wide variety of procedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections including the following:
Validation Services
Clean Room and HVAC/AHU Validation/Qualification
Compressed Air/Nitrogen Gas Testing or Validation
Pure steam Quality test
Documentation services
Equipment validation
Facilities validation
HVAC system validation
Cleaning validation
Process Validation
Analytical method validation
Computer system validation
Packaging validation
Cold chain validation
Compressed Air Validation
HVAC Validation
Clean Room Validation
Cold chain Validation
PLC Validation
Thermal Validation
Steam Quality Test
Design validation services
Pharma Validation Services
Data-verification validation services
Clean Room AHU Area Validation Services
Calibration validation
Equipment Validation Services
Flow Calibration
IAQ - Indoor Air Quality
Isolator Validation
Biosafety, LAF Validation
The Validation Process:
The validation scope, boundaries and responsibilities for each process or groups of similar processes or similar equipment's must be documented and approved in a validation plan. These documents, terms and references for the protocol authors are for use in setting the scope of their protocols. It must be based on a Validation Risk Assessment (VRA) to ensure that the scope of validation being authorised is appropriate for the complexity and importance of the equipment or process under validation. Within the references given in the VP the protocol authors must ensure that all aspects of the process or equipment under qualification; that may affect the efficacy, quality and or records of the product are properly qualified. Qualification includes the following steps:
Design qualification (DQ)
Demonstrates that the proposed design (or the existing design for an off-the-shelf item) will satisfy all the requirements that are defined and detailed in the User Requirements Specification (URS). Satisfactory execution of the DQ is a mandatory requirement before construction (or procurement) of the new design can be authorised.
Installation qualification (IQ)
Demonstrates that the process or equipment meets all specifications, is installed correctly, and all required components and documentation needed for continued operation are installed and in place.
Operational qualification (OQ)
Demonstrates that all facets of the process or equipment are operating correctly.
Performance qualification (PQ)
Demonstrates that the process or equipment performs as intended in a consistent manner over time.
Component qualification (CQ)
This term refers to the manufacturing of auxiliary components to ensure that they are manufactured to the correct design criteria. This could include packaging components such as folding cartons, shipping cases, labels or even phase change material. All of these components must have some type of random inspection to ensure that the third party manufacturer's process is consistently producing components that are used in the world of GMP at drug or biologic manufacturer.
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